The Medical Devices (Amendment) (EU Exit) Regulations 2021

Amendment of the Medical Devices Regulations 2002

2.  The Medical Devices Regulations 2002(1) are amended in accordance with Schedule 1.

(1)

S.I.2002/618. Paragraph 2(d) of Schedule 2 to S.I. 2020/1478 amended S.I. 2019/791 so that, on the coming into force of 2019/791, S.I. 2002/618, in so far as it applied to Great Britain, contained an application provision (regulation 1(2A)) to the effect that it only applied to Great Britain. Immediately beforehand, by virtue of Schedule 1 to S.I. 2020/1478, amendments were made to S.I. 2002/618, but only in so far as it applied to Northern Ireland. Accordingly, as a consequence of amendments made to S.I. 2002/618 by S.I. 2019/791 (as amended by S.I. 2019/1385 and 2020/1478) and by S.I. 2020/1478, two substantially different versions of S.I. 2002/618 have been in force since 31st December 2020 at 11p.m., one that applies in Great Britain and the other in Northern Ireland. These Regulations only amend the version of S.I. 2002/618 that applies in Great Britain.